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LABELS · 8f385b9e-2699-46a0-8c5f-ec1d86cd609d

Zirabev

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-07-21
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of: • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : ZIRABEV is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) • Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) • Recurrent glioblastoma in adults. ( 1.3 ) • Metastatic renal cell carcinoma in combination with interferon alfa. ( 1.4 ) • Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. ( 1.5 ) • Epithelial ovarian, fallopian tube, or primary peritoneal cancer: o in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, for stage III or IV disease following initial surgical resection. ( 1.6 ) o in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens. ( 1.6 ) o in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by ZIRABEV as a single agent, for platinum-sensitive recurrent disease. ( 1.6 ) 1.1 Metastatic Colorectal Cancer ZIRABEV, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). ZIRABEV, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer ZIRABEV, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. 1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. ZIRABEV, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. ZIRABEV, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Full extracted label fields
application numbers
  1. BLA761099
boxed warning exact
    brand names
    1. Zirabev
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa27acbd-d117-4350-aeee-17bc2e2c0ca4
    generic names
    1. BEVACIZUMAB-BVZR
    id
    8f385b9e-2699-46a0-8c5f-ec1d86cd609d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of: • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : ZIRABEV is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) • Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) • Recurrent glioblastoma in adults. ( 1.3 ) • Metastatic renal cell carcinoma in combination with interferon alfa. ( 1.4 ) • Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. ( 1.5 ) • Epithelial ovarian, fallopian tube, or primary peritoneal cancer: o in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, for stage III or IV disease following initial surgical resection. ( 1.6 ) o in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens. ( 1.6 ) o in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by ZIRABEV as a single agent, for platinum-sensitive recurrent disease. ( 1.6 ) 1.1 Metastatic Colorectal Cancer ZIRABEV, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). ZIRABEV, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer ZIRABEV, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. 1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. ZIRABEV, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. ZIRABEV, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Pfizer Laboratories Div Pfizer Inc
      matched search terms
      1. cancer
      2. carcinoma
      3. glioblastoma
      package ndcs
      1. 0069-0315-01
      2. 0069-0342-01
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      1. 0069-0315
      2. 0069-0342
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration, Preparation and Administration ( 2.9 ) 8/2024
      record type
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      1. INTRAVENOUS
      rxcuis
      1. 2268039
      2. 2268044
      3. 2268047
      4. 2268048
      source batch
      file
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      meta
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      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
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      source url
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      spl effective date
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      spl effective time
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      1. BEVACIZUMAB
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      1. application number
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        payload
        all indexed label documents
        1. Appl No
          761099
          Application Docs Date
          2019-06-28 00:00:00
          Application Docs ID
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          0
          Application Docs Type ID
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          Submission No
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        2. Appl No
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          Application Docs Date
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          Application Docs ID
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          Submission No
          6
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        3. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Type ID
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          Submission No
          4
          Submission Type
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        4. Appl No
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          Application Docs Date
          2023-02-22 00:00:00
          Application Docs ID
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          0
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          Submission No
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        5. Appl No
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          Application Docs Date
          2024-08-29 00:00:00
          Application Docs ID
          79506
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
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        all submission records
        1. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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        2. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        3. Appl No
          761099
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2021-02-09 00:00:00
          Submission Type
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          Submissions Public Notes
        4. Appl No
          761099
          Review Priority
          UNKNOWN
          Submission Class Code ID
          1
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2023-02-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          761099
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2024-08-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761099
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
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        latest label selection rule
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        latest posted label documents
        1. Appl No
          761099
          Application Docs Date
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          Application Docs ID
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          Application Docs Title
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          Application Docs Type ID
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          Submission No
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
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        Sponsor Name
        PFIZER INC
        openfda application present
        true
        products
        1. Active Ingredient
          BEVACIZUMAB-BVZR
          Appl No
          761099
          Drug Name
          ZIRABEV
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          100MG/4ML
          marketing status
          1. Prescription
        2. Active Ingredient
          BEVACIZUMAB-BVZR
          Appl No
          761099
          Drug Name
          ZIRABEV
          Form
          INJECTABLE;INJECTION
          Product No
          002
          Reference Drug
          0
          Reference Standard
          0
          Strength
          400MG/16ML
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
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      1 INDICATIONS AND USAGE ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of: • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) • Metastatic colorectal cancer, in combination with fluoro
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          1 INDICATIONS AND USAGE ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of:
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          1 INDICATIONS AND USAGE ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of: • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed o
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                              Passage 9 · unclassified context
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                                    Passage 11 · unclassified context
                                    application numbers
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                                    advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) • Recurrent glioblastoma in adults. ( 1.3 ) • Metastatic renal cell carcinoma in combination with interferon alfa. ( 1.4 ) • Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. ( 1.5 ) • Epithelial ovarian, fallopian tube, or primary peri
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                                      896
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                                      897
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                                      Source null
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                                      Passage 12 · unclassified context
                                      application numbers
                                      1. BLA761099
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                                                    Passage 17 · unclassified context
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                                                            Colorectal Cancer ZIRABEV, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). ZIRABEV, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer ZIRABEV, in combination with
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                                                              ZIRABEV, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
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                                                                  on with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Ce
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                                                                    1.3 Recurrent Glioblastoma ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
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                                                                    locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent,
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                                                                      1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the
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                                                                      Metastatic Renal Cell Carcinoma ZIRABEV
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                                                                      1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
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                                                                      1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
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                                                                      of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. 1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, is indicated for the treatment of
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                                                                        metastatic cervical cancer
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                                                                        1.5 Persistent, Recurrent, or Metastatic Cervical Cancer ZIRABEV, in combination with
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                                                                        not_inferred
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                                                                        kind
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                                                                        Metastatic Cervical Cancer ZIRABEV
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                                                                        is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
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                                                                        rsistent, Recurrent, or Metastatic Cervical Cancer ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
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                                                                        in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer
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                                                                          definition exact
                                                                          non–small cell lung cancer
                                                                          definition span
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                                                                          non–small cell lung cancer (NSCLC)
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                                                                        1.5 Persistent, Recurrent, or Metastatic Cervical Cancer ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
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                                                                        Source null
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                                                                        limitations
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                                                                        line
                                                                        Source null
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                                                                        regimen
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                                                                        tumor histology
                                                                        Source null
                                                                        use intent
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                                                                        application numbers
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                                                                        brand names
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                                                                        classification reasons
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                                                                        ervical Cancer ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. 1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. ZIRABEV, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube
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                                                                              Preserved source evidence · Not medical advice